This invention relates to an apparatus and method for endoluminally deploying a graft in a body passageway, for example, for the purpose of isolating an abdominal aortic aneurysm in the vicinity of a branching portion of vasculature.
Marin et al. U.S. Pat. No. 5,507,769 describes a method and apparatus for endoluminally deploying a graft across an aortic aneurysm and associated common iliac aneurysms. In that patent, separate grafts are advanced through a patient""s femoral and iliac arteries and aligned in a common region in the aorta above the aneurysm. Cephalic stents are deployed in that region to effectively create a bifurcated graft with the individual legs of the graft extending into the patient""s arteries. Suitable stents are likewise deployed in these legs caudal of the aneurysm, thus isolating the aneurysm. See also Palmaz et al. U.S. Pat. Nos. 5,316,023 and 5,571,170.
Marin et al. U.S. Pat. No. 5,507,769, which issued Apr. 16, 1996, Palmaz et al. U.S. Pat. No. 5,316,023, which issued May 31, 1994, and Palmaz et al. U.S. Pat. No. 5,571,170, which issued Nov. 5, 1996, in their entireties are hereby incorporated by reference.
One problem that must be contended with when deploying separate grafts for alignment in a common region of a patient""s vasculature is ensuring that a pathological defect has been effectively isolated because failure to do so may result in complications to the patient. There exists a need in the art for an apparatus and method for bypassing and effectively isolating a pathological defect, such as an abdominal aortic aneurysm, and an object of the invention is to satisfy that need and provide other advantages as set forth in the following description.
These and other needs are addressed, according to one aspect of the invention, by a method for endoluminally excluding a pathological defect in the vicinity of a branching passageway within a patient, such as an infrarenal aortic aneurysm. The method comprises the steps of introducing first and second graftstents through respective first and second access sites on one side of the pathological defect. The first and second graftstents are advanced until each extends across the pathological defect and is positioned in a common body passageway. The graftstents are joined together on the other side of the pathological defect within the common body passageway. The joining step may comprise tying the first and second graftstents together. When the pathological defect, e.g., an aneurysm, is in the aortic artery, the graftstents are advanced through the femoral and iliac arterial system and secured in a common region above the aneurysm. Of course, the method may be performed in passageways other than those that form the arterial system, and may be performed by advancing the graftstent from a common passageway to a branched passageway. When the inventive method is performed in the vascular system, the deployed vascular stents are preferably shaped in a noncircular configuration when expanded, for example, in a generally xe2x80x9cDxe2x80x9d shaped configuration and may be expanded simultaneously, as described in U.S. Pat. No. 5,507,769 for METHOD AND APPARATUS FOR FORMING AN ENDOLUMINAL BIFURCATED GRAFT, issued Apr. 16, 1996, the entirety of which is hereby incorporated by reference as if set forth herein. The deployed stents preferably hemostatically seal the graftstents to the common vessel wall and to each other so that blood is excluded from the aneurysmal cavity. One advantage of this system is the ability to use smaller delivery catheters in each vascular branch rather than one larger catheter sized to deploy a graft which is sufficiently large to bypass the aorta.
According to yet another aspect of the present invention, a graftstent for hemostatically bypassing an aneurysm is provided. The graftstent comprises a segment of graft material having serially spaced support hoops, for example, made of nitinol, a nitinol or self-expanding stent, and an elongated line or tab (attached to the end opposite the stent) that extends from the patient so that tension applied to the line or tab from outside the patient positions one end of the graftstent relative to the other. The segment of graft material connects at one end to a balloon-expandable stent and at another end to the self-expanding stent. The graftstent may have the segment of graft material cut on a bias, as noted above.
According to still another aspect of the invention, left and right graftstents are aligned and anchored in situ by advancing a knot or anchor bead from a location external to the patient to the site where the left and right graftstents have been advanced. In the case of an anchor bead, the bead is provided with a plurality of funnel-like seal rings which provide little resistance to movement in a first direction yet great resistance to movement in a second, opposite direction. The anchor bead can be advanced over an anchor line threaded through the left and right grafts to draw the graftstents together. Once drawn together, the knot or anchor bead junction prevents the graftstents from separating, and ensures alignment of both graftstents to each other, both rotational and longitudinal, thereby assuring proper deployment of both graftstents and exclusion of the aneurysm.
According to a further aspect of the invention, a graftstent system is disclosed which comprises a first graftstent, a second graftstent, and an endoluminal connector. The connector has a first portion that attaches to the first graftstent and a second portion that attaches to the second graftstent. The connector is adjustable to endoluminally join the first and second graftstents.
These and other objects, features and advantages of the present invention will be readily apparent from the following detailed description of the invention taken in conjunction with the accompanying drawings.